FDA.reportPublic FDA data

Application 022150

Type
NDA
Sponsor
SHIRE ORPHAN THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FIRAZYRICATIBANT ACETATEINJECTABLE;SUBCUTANEOUSEQ 30MG BASE/3ML (EQ 10MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54092-135IcatibantIcatibantTakeda Pharmaceuticals America, Inc.NDA AUTHORIZED GENERICCurrent
54092-135IcatibantIcatibantTakeda Pharmaceuticals America, Inc.NDA AUTHORIZED GENERICCurrent
54092-135Firazyricatibant acetateShire US Manufacturing Inc.NDA AUTHORIZED GENERICCurrent
54092-702Firazyricatibant acetateShire US Manufacturing Inc.NDACurrent
54092-702Firazyricatibant acetateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-702Firazyricatibant acetateShire US Manufacturing Inc.NDACurrent
54092-702Firazyricatibant acetateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-702Firazyricatibant acetateTakeda Pharmaceuticals America, Inc.NDACurrent
54092-702Firazyricatibant acetateShire US Manufacturing Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77278SUPPL 2024-01-23
77266SUPPL 2024-01-23
70916SUPPL2022-05-03
70882SUPPL2022-05-02
62588SUPPL2020-04-17
62587SUPPL2020-04-17
62586SUPPL2020-04-17
62585SUPPL2020-04-17
17018SUPPL2015-11-25
6966SUPPL2015-11-25
17017SUPPL2015-08-11
6965SUPPL2015-08-11
17016SUPPL2013-09-09
29323SUPPL2013-09-04
42431ORIG2011-10-03
29322ORIG2011-08-29
17015ORIG2011-08-26